3D Ultrasound for Breast Disease

Overseen By Anat Kornecki, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Breast implants, ABUS contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D ultrasound method for identifying tumors and other key features in the breast. Participants will have additional 3D images taken during their regular mammogram and ultrasound appointments. The goal is to determine if the 3D images offer a clearer view than the standard 2D ultrasound. Females scheduled for routine breast screening or short-term follow-up with ultrasound may qualify, provided they do not have breast implants. As an unphased trial, this study allows participants to contribute to innovative imaging techniques that could improve breast cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D ultrasound device is safe for breast imaging?

Research has shown that 3D ultrasound for breast imaging is generally well-received by patients. Studies indicate that automated 3D ultrasound can help detect breast cancer, especially in women with dense breast tissue. This method supports existing screening techniques, ensuring safety. Its accuracy is similar to that of regular mammograms, which is a positive indicator for safety. Although this study uses a new device for 3D imaging, the overall technique has been safely used in other contexts. Therefore, prospective trial participants can feel confident about the procedure's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D ultrasound for breast disease because it offers a new way to visualize breast tissue in three dimensions, unlike traditional 2D mammograms and ultrasounds. This advanced imaging technique could provide more detailed and accurate insights into breast abnormalities, potentially leading to earlier and more precise detection of breast cancer. By capturing comprehensive 3D volumes, it aims to reduce false positives and negatives, which are common challenges with current screening methods. This could significantly improve patient outcomes by ensuring timely and accurate diagnosis.

What evidence suggests that this 3D ultrasound device is effective for breast disease?

Research shows that 3D ultrasound imaging effectively detects breast cancer that a regular mammogram might miss, especially in women with dense breast tissue. Studies have found that 3D automated breast ultrasound (3D ABUS) can detect more cancer cases, with a detection rate of 1.9 to 7.7 per 1000 women screened. This method provides a clearer view of breast tissue, making tumors easier to spot compared to traditional 2D imaging. These findings suggest that 3D ultrasound could be a valuable tool for early cancer detection, offering more detailed images than standard methods. Participants in this trial will be imaged with an experimental device designed to acquire ultrasound in three-dimensional volumes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult females at least 18 years old, scheduled for mammography and ultrasound assessment for breast disease. Participants must be proficient in English to understand the procedure and give informed consent.

Inclusion Criteria

I am scheduled for an ABUS breast screening.

I am scheduled for a short-term Automated Breast Ultrasound.

You possess a proficient level of English literacy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo routine 2D ultrasound and additional 3D ultrasound imaging using a custom device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

24 months

What Are the Treatments Tested in This Trial?

Interventions

• 3D Ultrasound Image Acquisition

Trial Overview

The study tests a custom device developed by Dr. Aaron Fenster's lab that acquires 3D ultrasound images using a commercial machine, comparing its effectiveness with GE Medical's InveniaTM clinical system.

How Is the Trial Designed?

Group I: Patients at Risk of Breast Cancer Experimental Treatment 1 Intervention

These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

Three-dimensional (3-D) ultrasound provides a comprehensive and automated scanning of the breast, which enhances the reliability of reviews and follow-ups compared to traditional ultrasound methods.

This technique has the potential to be integrated into routine radiological practices and could be beneficial for population screening programs for breast cancer, improving early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[3-D ultrasound of the breast: less dependent on the investigator]. de Jong, MD., Dubelaar, IJ., Fassaert, TA., et al.[2016]

In a review of over 201,000 administrations of ultrasound enhancement agents (UEAs), severe and critical adverse drug reactions (ADRs) were found to be more frequent with Lumason compared to Definity, with rates of 0.0848% for severe and 0.0330% for critical ADRs associated with Lumason.

The frequency of severe ADRs with Lumason has increased in recent years, and patients experiencing these reactions were more likely to have received a COVID-19 vaccination, particularly the Moderna vaccine, suggesting a potential link that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice. Ali, MT., Johnson, M., Irwin, T., et al.[2023]

In a study involving 34 pediatric patients with solid tumors, the intravenous administration of ultrasound contrast agents was found to be safe, with no significant changes in hemodynamic status observed during or after the procedure.

Only 2.2% of the procedures resulted in mild, transient side effects, such as taste alteration and tinnitus, which did not recur in subsequent examinations, indicating a favorable safety profile for these agents in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. Coleman, JL., Navid, F., Furman, WL., et al.[2021]

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

Three-dimensional (3D) ultrasound provides different characteristics for breast lesions compared to conventional two-dimensional (2D) ultrasound, particularly highlighting the retraction phenomenon as a significant factor in lesion characterization.

Despite the differences in ultrasound features, the diagnostic accuracy of 3D and 2D ultrasound is nearly identical, suggesting that 3D ultrasound could be a valuable adjunct to 2D ultrasound in breast imaging, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasound for the assessment of breast lesions. Watermann, DO., Földi, M., Hanjalic-Beck, A., et al.[2019]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

The study analyzed 221 breast tumors using 3D ultrasonography and found that the convergence sign is significantly associated with various prognostic factors, including smaller tumor size and positive hormone receptor status, indicating its potential as a predictive marker for breast cancer prognosis.

Irregular tumor margins observed in 3D ultrasonography were linked to axillary lymph node metastases and negative C-erb-B2 expression, suggesting that these imaging characteristics can help inform treatment decisions for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional ultrasonography for the prediction of breast cancer prognosis. Xu, G., Han, T., Yao, MH., et al.[2016]

3D ultrasonography provided superior image quality compared to 2D ultrasonography when evaluating 507 solid breast masses, particularly for larger masses over 10 mm.

Despite the improved image quality with 3D imaging, there was no significant difference in diagnostic accuracy for breast cancer detection when compared to 2D imaging, indicating that both methods are equally effective in diagnosing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses. Cho, KR., Seo, BK., Lee, JY., et al.[2016]

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

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Recommendation: Breast Cancer: Screening

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mayoclinic.org

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3D mammogram

The test gives a low level of radiation. A 3D mammogram uses X-rays to create an image of the breast, which exposes you to a low level of ...

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ajronline.org

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Automated Breast Ultrasound in Breast Cancer Screening ...

Combining mammography with ABUS, compared with mammography alone, significantly improved readers' detection of breast cancers in women with dense breast tissue.